BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 3178677 · Received June 19, 2013

    Report

    Report Number
    9611451-2013-00479
    Event Type
    Malfunction
    Date Received
    June 19, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 21, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE IN THE PROCESS OF OBTAINING THE COMPLAINT DEVICES FROM THE HEALTHCARE FACILITY FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4) IT WAS REPORTED THAT THE GAS OUTLET PORT WAS BROKEN ON THREE RD900 NEOPUFF DEVICES, TWO FROM LOT 091207 AND ONE FROM 090203. METHOD: ONLY THE 900RD010 T-PIECE CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) WHERE IT WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED THAT THE T-PIECE CIRCUIT WAS RETURNED WITH A BROKEN GAS OUTLET PORT FROM A NEOPUFF DEVICE STILL CONNECTED TO ONE END OF THE RETURNED T-PIECE CIRCUIT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOTS 090203 AND 091207. CONCLUSION: THE NEOPUFF IS A PORTABLE, REUSABLE DEVICE USED TO ASSIST IN THE DELIVERY OF RESPIRATORY BREATHS TO INFANTS UNTIL ADEQUATE SPONTANEOUS BREATHING OCCURS. BEING A PORTABLE DEVICE, THE NEOPUFF CAN BE SUSCEPTIBLE TO IMPACT DAMAGE, FOR INSTANCE WHEN ACCIDENTALLY DROPPED OR SUBJECTED TO CONSIDERABLE EXTERNAL FORCE. THE NEOPUFF TECHNICAL MANUAL WARNS AGAINST DROPPING THE NEOPUFF OR SUBJECTING IT TO IMPACT DAMAGE WHICH MAY CAUSE THE UNIT TO OPERATE INCORRECTLY. IF THE NEOPUFF IS SUSPECTED TO HAVE BEEN DAMAGED, THE MANOMETER AND VALVE SYSTEM SHOULD BE PERFORMANCE TESTED. THE HOSPITAL CORRECTLY IDENTIFIED THE FAULT DURING SET UP AS INDICATED IN OUR UI. THE NEOPUFF TECHNICAL MANUAL STATES THE FOLLOWING: "DROPPING THE NEOPUFF / PERIVENT INFANT RESUSCITATOR OR OTHER SIMILAR FORMS OF IMPACT MAY CAUSE DAMAGE RESULTING IN INCORRECT OPERATION OF THE UNIT. IF YOU SUSPECT DAMAGE TO HAVE OCCURRED, PLEASE PERFORM CHECKS AS OUTLINED [IN THE MANUAL] BEFORE CONNECTION TO A PATIENT".

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE GAS OUTLET PORT ON THREE RD900 NEOPUFF RESUSCITATORS BROKE WHEN THEY CONNECTED THE 900RD010 T-PIECE CIRCUIT. THIS WAS FOUND DURING SET UP AND PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE GAS OUTLET PORT ON THREE RD900 NEOPUFF RESUSCITATORS BROKE WHEN THEY CONNECTED THE 900RD010 T-PIECE CIRCUIT. THIS WAS FOUND DURING SET UP AND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278632 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LTD RD900 090203

    Patients

    Seq Age Sex Outcome Treatment
    1 900RD010 T-PIECE CIRCUIT| 900RD010 T-PIECE CIRCUIT